Clinical Trial

Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients

Study acronym: VALPAIN-HD
Not Yet Recruiting
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Record status
This record was last updated July 15, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients. The main questions it aims to answer are: Does the Valsalva maneuver effectively reduce pain intensity during AVF cannulation as measured by the Visual Analogue Scale (VAS)? Is the Valsalva maneuver feasible, acceptable, and satisfactory for patients, and can it be sustainably implemented over multiple sessions? Researchers will compare patients performing the Valsalva maneuver (intervention group) with those receiving standard care without any intervention (control group) to see if pain scores are significantly lower and whether patients are willing to continue using this technique voluntarily. Participants will: Receive training and supervised practice on the Valsalva maneuver before inclusion in the study Perform the Valsalva maneuver during AVF cannulation in each hemodialysis session for 12 sessions Complete VAS pain assessments after each session Complete a patient satisfaction and feasibility form at the end of the study
Trial Details
NCT Number NCT07066579
Lead Sponsor Cansu POLAT DÜNYA
Collaborators: Istanbul University Scientific Research Projects Coordination Unit- Pending
Conditions Arteriovenous Fistula, Pain, Hemodialysis Access Failure, Vascular Access Device Complications
Enrollment 60 participants
Start Date 2025-09-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-15